Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha Photon Counting-detector CT Before Transcatheter Aortic Valve Implantation

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

The clinical and demographic characteristics of patients undergoing transcatheter aortic valve implantation (TAVI) pose unique challenges for coronary computed tomography (CT) imaging, as this patient population is mainly composed of elderly, frail individuals with severe aortic stenosis, multiple comorbidities, high prevalence of heavily calcified coronary artery disease (CAD) and revascularized coronary arteries. Such vulnerable patients could benefit from a more precise assessment and characterization of their CAD with ultra-high resolution (UHR) photon-counting detector (PCD) CT that would potentially avoid the need for pre-implantation invasive coronary angiography (ICA). This international multicenter prospective registry study aims to investigate the feasibility and diagnostic accuracy of PCD-CT in the assessment of CAD in the high-risk population of patients undergoing TAVI, as compared to ICA.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Clinically indicated TAVI

• Clinically indicated CT and invasive coronary angiography

• There are no contraindications to CT angiography.

• Understanding and signing the consent form

Locations
United States
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Other Locations
Germany
Albert-Ludwigs-Universität Freiburg
NOT_YET_RECRUITING
Freiburg Im Breisgau
University Medical Center Mainz
RECRUITING
Mainz
Universitätsklinikum Tübingen
NOT_YET_RECRUITING
Tübingen
Hungary
Semmelweis University
RECRUITING
Budapest
Netherlands
Maastricht University
NOT_YET_RECRUITING
Maastricht
Switzerland
University Hospital of Zürich
NOT_YET_RECRUITING
Zurich
Contact Information
Primary
Pál Maurovich-Horvat, MD, PhD, DSc
maurovich-horvat.pal@semmelweis.hu
+3614591500
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2030-05-30
Participants
Target number of participants: 1000
Treatments
Aortic stenosis
Patients with aortic valve disease for whom transcatheter aortic valve implantation is indicated and who present for pre-interventional evaluation will be enrolled after written consent.
Sponsors
Collaborators: Siemens Corporation, Corporate Technology
Leads: Semmelweis University

This content was sourced from clinicaltrials.gov